Intra-articular Viscosupplement Application in Knee Osteoarthritis

NCT03913052 | Unknown DMC

• 1 other identifier: OA2018
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (OA) is one of the common diseases which causes pain and disability with increasing age. In developed countries, it is said to be one of the ten diseases which decreases functionality most.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Biodex (System 3) isokinetic systems

  Isokinetic test are measured with Biodex (System 3) for the measurement of quadriceps muscle strength before and 3 months after injection. Measurements are performed at angular speeds of 60°. Biodex (System 3) isokinetic systems are used to evaluate knee flexion angles and the muscle strengths applied at these angular velocities. The device is set to measure at angular speeds of 60°. Knee extension and flexion are requested and the best measurement is made. By this measurement, the effect of injection on quadriceps isokinetic muscle strength will be determined.

  5 minutes

Study Arms (1)

Injection

EXPERIMENTAL

Injection containing hyaluronic acid, chondroitin sulphate and glucosamine was performed once when the knee joint was in the supine position and the knee was in the extension.

Procedure: Intra-articular Viscosupplement Application

Interventions

Intra-articular Viscosupplement Application PROCEDURE

Injection containing hyaluronic acid, chondroitin sulphate and glucosamine is performed once when the knee joint was in the supine position and the knee is in the extension.

Also known as: intra-articular injection

Injection

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being between 40-65 years of age,
• being diagnosed with Stage 3 and 4 knee OA according to the Kellgren-Lawrence classification

You may not qualify if:

• any lower extremity deformity (knee flexion contracture, knee hyperextension, varus and valgus deformities),
• septic arthritis, rheumatoid arthritis,
• major dysplasia,
• congenital anomalies, acromegaly, primary osteochondromatosis,
• Ehler-Danlos syndrome,
• neuropathic arthropathy,
• hyperparathyroidism, hypothyroidism,
• diabetes mellitus,
• active synovitis,
• severe knee traumas,
• previous surgery and in the last year,
• knee arthroscopy, injections and fracture history and pregnancy

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Tomri̇s Duymaz

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Tomri̇s Duymaz

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Ph.D.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 12, 2019
• Study Start: November 2, 2018
• Primary Completion: February 28, 2019
• Study Completion: April 10, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)